POC STI Testing Reduces Time from ER Arrival to Test Results
By the LabMedica editorial team in Spanish
Updated on June 13, 2024
In a 2024 sexually transmitted infection (STI) surveillance report by the World Health Organization (WHO), more than 2.5 million cases were recorded, along with an increase in inappropriate use of antibiotics to treat these STIs. This misuse has contributed to the development of strains of Neisseria gonorrhoeae (NG) resistant to antimicrobials, which has led the WHO to publish new guidelines for the diagnosis of STIs, including the use of point-of-care (POC) testing, particularly focusing on reducing antimicrobial resistance. Rising rates of STIs have posed a significant challenge for hospital emergency departments, as traditional tests do not return results quickly enough to guide treatment decisions during the patient visit. Consequently, doctors often must decide on treatment before obtaining definitive results, exacerbating the problem of antibiotic resistance.
Now, a new study has shown that a point-of-care (POC) polymerase chain reaction (PCR) test can reduce the time from sample collection to STI result to just 47 minutes per patient, in compared to the average of 25 hours with laboratory-processed molecular tests according to the standard of care (SOC). This trial also led to significantly higher rates of appropriate treatment and lower rates of overtreatment with antibiotics for infections. Chlamydia trachomatis (CT) and NG, in relation to the SOC. Conducted by Visby Medical (San Jose, CA, USA) and John Hopkins University (Baltimore, MD, USA), the study evaluated a new approach to managing the three most common non-viral STIs in women, comparing two testing methods at the Johns Hopkins Emergency Department during two separate four-month study periods in 2022 and 2023.
Image: POC PCR test shortens time to STI test results (photo courtesy of Visby Medical)
The two methods included testing from the SOC central laboratory with batch nucleic acid amplification testing (NAAT) and the Visby Meidcal POC PCR sexual health test. STI detection rates, median time intervals to results, and rates of appropriate treatment were evaluated according to CDC guidelines. Visby Medical’s sexual health test, an “instrument-free” POC test that delivers PCR results in less than 30 minutes, is the only one of its kind available in the United States. In March 2023, this test received 510(k) clearance and a CLIA. exemption from the US Food and Drug Administration for its second-generation POC test. The study found that proportions of appropriate treatment were significantly higher in the POC group. Additionally, the median time intervals for the POC group were significantly shorter, including the time from specimen collection to STI results, the time from patient arrival to the emergency department to STI results, and the time from arrival at the emergency department to discharge of the patient.
“The dramatic improvements seen with the Visby Sexual Health test in testing time, duration of ED visits, and antibiotic use point the way to a new best practice for STI testing,” said Dr. Gary Schoolnik, infectious disease expert, medical director of Visby Medical and professor of medicine at Stanford University. “Implementing a new standard of care of rapid point-of-care testing would greatly benefit our hospitals, urgent care centers, and most importantly, women seeking treatment for this condition.”
Related links:
Visby Medical
John Hopkins University
